The UK’s plans to leave the European Union (EU) and the EU’s single market could have serious implications for patients’ access to medicines and medical technologies.
Certain medicines and medical technologies may be delayed in reaching patients or may even become unavailable to patients if no solution for medicines and medical devices is found during the Brexit negotiations.
This briefing from the Brexit Health Alliance - "Brexit and the impact on patient access to medicines and medical technologies" - explores how UK and EU citizens could be affected by the disruption in trade that may result from the UK’s exit from the EU, as well as in the event of a lack of cooperation in the regulation of medicines and devices between the EU and the UK post-Brexit.
Industry preparedness for Brexit
The regulation of medicines and medical technologies is managed by EU-wide systems, facilitating trade under the single market. This means that products are regulated to make sure that they are safe before they can be placed on the EU market. They are also closely monitored after being placed on the market to ensure continued safety. Any changes to this regime may have an impact on supplies across Europe.
The European Medicines Agency continues to examine the possible changes to the regulatory regime that may result from the UK's leaving the EU and has released the results (10 June 2018) from its recent survey on the Brexit preparedness plans of marketing authorisation holders (MAHs) who have centrally authorised medicinal products (CAPs) located in the UK. The survey aimed to identify CAPs that are potentially at risk of supply shortages, to assess how critical these are and discuss relevant mitigation measures.
Results show that MAHs accounting for over half of the medicinal products in question are on track with the regulatory planning necessary to ensure that their products remain valid after the UK leaves the EU. In some cases this may entail changes to the marketing authorisation itself, including, for example, a transfer of the marketing authorisation to a legal entity established in the European Economic Area (EEA), or a change of the qualified person for pharmacovigilance (QPPV) to a location in the EEA.
The EMA is urging those companies who have not yet informed them of their Brexit preparedness plans to do so as soon as possible, to mitigate any risks to the continuous supply of medicines for human and veterinary use within the EU.
Brexit Health Alliance
As the EU and the UK prepare to move to phase two of the Article 50 negotiations, which will look at the future relationship between the EU and the UK, arrangements for the regulation of medicines and medical devices need be addressed as a matter of urgency.
The Brexit Health Alliance is calling for:
- No negative impact on patients. Future cooperation on medical devices and medicines to be prioritised in the negotiations, so that patients and the wider public are not negatively impacted from disruptions in the supply of medicines and other health technologies, or from a reduction in standards or safety.
- Patient safety and public health to be guaranteed post Brexit through aligning the UK as much as possible with the EU’s regulation of medicines and medical devices, and by close regulatory cooperation between the EU and UK, as proposed by the UK government.
- Pragmatic solutions allowing patients and the public to benefit from the UK’s participation in EU systems such as data sharing networks, pharmacovigilance and the new clinical trials infrastructures post Brexit.
- An implementation period beyond the two years of Article 50 negotiations (which end in March 2019). This period should adequately reflect the time needed to ensure relevant customs, trade and regulatory procedures are in place.